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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

Overview

Status
Completed
Phase
Phase 2
Enrollment
79 participants (actual)
Sponsor
Yale University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Sept 2013
Primary completion
Jun 2018
Completion
Aug 2019
First posted
23 Aug 2013 (estimated)
Last update posted
19 Mar 2020
Conditions
Type I Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201620182020
  1. Ph 2

    A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

    NCT01928329

    Sept 2013 to Aug 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)

Interventions

  • Exenatide (Bydureon®)Drug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    2 mg, 1 per week via subcutaneous placebo self injection

  • Experimental

    Exenatide (Bydureon)

    2 mg, of drug administration 1 per week via subcutaneous self injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in HbA1c Levels

    Time frame · 6 months

Secondary outcomes(3)
  1. Change From Baseline in HbA1c Levels

    Time frame · 12 months

  2. Major Hypoglycemic Event Rate On Drug

    Time frame · Up to 6 months

    Registry description

    The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL.

  3. Major Hypoglycemic Event Rate Off Drug

    Time frame · Up to 12 months

    Registry description

    The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 6 months

Change From Baseline in HbA1c Levels

GroupValue (mmol/mol)Spread
Exenatide (Bydureon)-0.120.08
Placebo0.110.10
Secondary and other outcome results(3)
Secondary outcomeLeast squares mean· 12 months

Change From Baseline in HbA1c Levels

GroupValue (mmol/mol)Spread
Exenatide (Bydureon)0.080.09
Placebo0.100.10
Secondary outcomeMedian· Up to 6 months

Major Hypoglycemic Event Rate On Drug

GroupValue (events per month)
Exenatide (Bydureon)0.67
Placebo0.80
Secondary outcomeMedian· Up to 12 months

Major Hypoglycemic Event Rate Off Drug

GroupValue (events per month)
Exenatide (Bydureon)0.33
Placebo0.50

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide (Bydureon)2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)0 / 396 / 3939 / 39
Placebo2 mg, 1 per week via subcutaneous placebo self injection Placebo0 / 352 / 3528 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria * Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria. * Diagnosis of T1DM at least 2 years from Visit 0 * Insulin Requirement of ≤ 0.90 units/kg * Absence of ketoacidosis in the past 6 months * HbA1c of ≥ 6.5% and ≤ 9.5% * Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period * Signed informed consent Exclusion Criteria: * Inability or unwillingness to give informed consent * Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status. * Known hypersensitivity to Exenatide, Liraglutide or any product component. * Participation in an investigational treatment trial within the last 6 weeks before enrollment. * 1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months. * Another condition that would, in the view of the investigator, affect the safety of using Bydureon. This might include, among others a history of MEN 2, a history of medullary carcinoma of the thyroid or pancreatitis. * Known severe renal impairment, end-stage renal disease or renal transplantation. * Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma. * Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment. * Clinically active serious infection. * Positive pregnancy test in menstruating women or lactating females. * Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes medications other than insulin.

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